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EC number: 696-364-9
CAS number: 133779-11-0
Table 1: Dermal irritation of animal 1, 2
* : eschar formation
Acute dermal irritation/corrosion of
N-(hydrogenated tallow)-1,3-diaminopropane was investigated. The test
substance was ground finely by using a mortar before application of
0.5g. To ensure good contact, it was moistened with aqua ad inject.
Three female New Zealand White Rabbits were exposed 4h after
removing fur from the dorsal area of the trunk. At the end of the
exposure period, residual test substance was rinsed by using tap water
or aqua ad inject. Animals were examined for signs of erythema and
oedema at 1, 24, 48, 72h after patch removal. Then, animals were
observed daily for reversibility of irritating effects up to day 13.
Calculation of Primary Irritation Scores
(PIS) as an average value over 24h, 48h and 72h was calculated for
each animal. This yielded values of 4.7 (animal 1 and 3) and 5.0 (animal
2), respectively. Eschar formation was observed after 24h (animal 1) or
after 48h (animal 2 and 3), respectively. Irritant effects were fully
reversible within 9 or 14 days. Weight gain during the contact and
observation period was normal for all animals.
Considering the reported data of this
irritation study it can be stated that the test item N-(Hydrogenated
tallow)-1,3-diaminopropane showed well-defined to moderate irrant
effects, which were fully reversible 9 days after patch removal in
animal 1 and 13 days after patch removal in animals 2 and 3.
According to the EC criteria for
classification and labelling requirements for dangerous substances and
preparations (Guidelines in Commission Directive 2001/59/EC) the test
item N-(Hydrogenated tallow)-1,3-diaminopropane has to be classified and
has obligatory labelling requirement for skin irritation.
The test on acute dermal
irritation/corrosion was performed under GLP and similar to
guideline OECD Guideline 404, EU Method B.4 and EPA OPPTS 870.2500
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